Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

Adult ; Bronchoalveolar Lavage ; methods ; Humans ; Male ; Middle Aged ; Pneumoconiosis ; therapy ; Treatment Outcome

Objective To analyze the clinical data of patients with hilar cholangiocarcinoma (HCCA),and to compare the therapeutic effects of different methods on treating these patients.Methods The clinical data of 101 patients with HCCA in China-Japan Union Hospital of Jilin University were analyzed.Results The overall 1-year and 2-year survival rates in the radical operation group were 95.5％ and 40.9％,respectively.There was a significant difference between the radical operation group and the palliative resection group (P ＜ 0.05).The overall 1-year and 2-year survival rates in the palliative resection group were 75.0％ and 16.7％,respectively,which were much better than those in patients treated with PTCD,biliary stent on open abdominal biliary drainage (P ＜ 0.05).There were no significant differences among the PTCD,biliary stent and open abdominal biliary drainage groups (P ＞ 0.05).Conclusions Radical HCCA resection is still the best and the first choice treatment for patients with HCCA.The therapeutic effects of radical operation were much better than those of palliative resection,biliary stent,PTCD and open abdominal biliary drainage.

Objective To investigate the clinical effect of super selective embolization combined with opera-tion for treatment of meningiomas.Methods 82 cases treated by operation and pathology in return for meningioma were collected in the study,including 44 cases of preoperative superselective embolization for aneurysms as the treat-ment group,and the remaining 38 cases without preoperative embolization of patients as the control group.The opera-tion time,bleeding amount in the operation and the rate of total tumor removal were recorded and compared between the two groups.Results The average amount of bleeding of treatment group was (330.36 ±95.41)mL.The average amount of bleeding of control group was (460.82 ±114.64)mL.The data of the two groups was statistically significant (t =5.624,P <0.01).,The treatment group bleeding amount was less than that of the control group;,the mean oper-ation time of treatment group was (5.36 ±2.62)h,,the average operation time of control group was (6.63 ±2.25)h.The data of the two groups was statistically significant (t =2.355,P =0.021 ),the operation time of the treatment group was less than that of the control group.The total resection rate was 70.4% in treatment group and 36.8% in the control group,there was statistically significant (P <0.05),and the total resection rate in the treatment group was higher than that in the control group.Conclusion Compared with single operation treatment of meningiomas superse-lective embolization combined with operation for treatment of meningiomas can shorten operation time,reduce intraoperative hemorrhage,improve the rate of total tumor removal.It can reduce the operation risk and improve the treatment effect.

Adolescent ; Bone Diseases ; etiology ; Chronic Kidney Disease-Mineral and Bone Disorder ; complications ; pathology ; Facial Bones ; Female ; Humans ; Hyperparathyroidism, Secondary ; complications ; Kidney Failure, Chronic ; complications ; pathology ; Syndrome

Recently, the D'Amico classification system is widely used for the risk stratification of prostate cancer (PCa) , although no consensus has been reached for the definition of high-risk PCa. This system defines high-risk PCa as a prostate-specific antigen (PSA) level > 20 ng/ml, a Gleason score of 8-10, or a clinical stage ≥ T2c. Because high-risk PCa is prone to recurrence and metastasis after treatment, a proper initial therapy plays a crucial role. Currently, radical prostatectomy and radiation therapy are considered to be two most important options for the initial treatment of high-risk PCa although it remains controversial which is better.
Humans ; Male ; Neoplasm Grading ; Neoplasm Recurrence, Local ; Prostate-Specific Antigen ; blood ; Prostatectomy ; methods ; Prostatic Neoplasms ; blood ; pathology ; radiotherapy ; surgery ; Risk

OBJECTIVETo study topiramate's new functions according to the medicinal property combinations, in order to apply the traditional Chinese medicinal theory in discovering new purposes of old drugs.

METHODAccording to New Traditional Chinese Medicinal Families--Chemical Traditional Chinese Medicines, the authors found out topiramate's property. Then based on the therapeutic principle of diabetes, hypertension, epilepsy and lung cancer, as well as the relations of efficacies and medicinal property combinations, they summarized the corresponding medicinal property combination modes, compared topiramate's medicinal property combination mode with corresponding medicinal property combination modes of these diseases, and predict topiramate's new functions.

RESULTAccording to the comparison, the corresponding medicinal property combinations were consistent with topiramate's medicinal property combinations as evidenced by corresponding literatures, whereas other medicinal property combinations were not.

CONCLUSIONBased on medicinal property combination modes, the authors screened topiramate's new functions according to e of TCM clinical experience, discovered topiramate's therapeutic effects on diabetes, hypertension and lung cancer in addition to epilepsy, and explore new drug function according to medicinal property combination modes, which could help greatly shorten the new drug R&D period.

Diabetes Mellitus ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; chemistry ; therapeutic use ; Fructose ; analogs & derivatives ; chemistry ; therapeutic use ; Humans ; Hypertension ; drug therapy ; Lung Neoplasms ; drug therapy ; Phytotherapy

OBJECTIVE To study the carriage,the risk factors and the antibiotic resistant pattern of Streptococcus pneumoniae isolated from hospitalized children with respiratory infection below 3 years old.METHODS A total of 453 children with respiratory infection hospitalized at Children′s Hospital of Soochow University in Suzhou Jiangsu Province from Mar 2006 to Mar 2007 were enrolled and given deep orotracheal aspiration(OTA) technique to get the sputum.S.pneumoniae strains were tested and analyzed.RESULTS The carriage rate of S.pneumoniae was 9.3% which was related with age and season.The percentage of resistance to penicillin,erythromycin,tetracycline,clindamycin,chloramphenicol and trimethoprim/sulfamethoxazole was 16.7%,100%,95.2%,95.2%,14.3% and 73.8%,respectively.No resistant strains to ceftriaxone,ofloxacin and vancomycin were detected.All S.pneumoniae strains were resistant to multiple drugs.CONCLUSIONS The carriage of S.pneumoniae in respiratory infected children below 3 years old in Suzhou area is relatively low.Age and incidence season are the risk factors.The antibiotic resistance is serious.

Objective To study endothelial nitric oxide synthase (eNOS) gene transfecting endothelial cells (ECs). Methods eNOS gene was transfected into the steady ECs system by cationic liposomal transduction and check the transfection effect by RT-PCR and immunohistochemistry assay. To test the concentrations of NOS, nitric oxide (NO) and von willebrand factor (vWF) in culture media by colorimetry and ELISA, respectively,and transfected EC function was observed. Results The effect of transfection was satisfactory with RT-PCR products electrophoresis, sequence and immunohistochemistry. The concentrations of NOS and NO in transfected EC culture media increased with time (P

Objective To analyze the spectrum of anus disease during the medical selection of flying cadets and com-pare the medical standard between US Air Force and Chinese Air Force in order to improve the system of medical selection. Methods The data on flying cadets of Chinese Air Force medical selection from 2012 to 2015 were retrospectively analyzed and these data were re-analyzed by medical standards for US Air Force flying cadets.Results Ninety students were elimi-nated because of anal disease,including 65 hemorrhoids,14 fistula and 11 fissure.The rate of disqualification from 2012 to 2015 was 48.28%, 33.33%, 31.37%, 39.69%and there was no significant statistical difference between each two years (x2 =2.6154,P=0.4548).There was statistically significant difference(P=0<0.05)in hemorrhoids standards between CAF and USAF,and significant difference in fistula and fissure standards.Conclusion Compared with Chinese medical se-lection standards,the US Air Force standards focus on whether the symptoms of disease have effect on air safety and effi-ciency.To improve our medical selection standards,we need to learn from foreign air forces and take our own conditions into account.